Semi-automatic Biopsy Needle - BIM18/20i

GUDID 04262410687028

The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate).

ITP Innovative Tomography Products GmbH

End-cut biopsy gun handpiece/needle
Primary Device ID04262410687028
NIH Device Record Key020dc097-bd59-4d40-9deb-b185ba100006
Commercial Distribution StatusIn Commercial Distribution
Brand NameSemi-automatic Biopsy Needle - BIM18/20i
Version Model NumberBIM18/20i
Company DUNS341493551
Company NameITP Innovative Tomography Products GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com

Device Dimensions

Length200 Millimeter
Needle Gauge18 Gauge
Length200 Millimeter
Needle Gauge18 Gauge
Length200 Millimeter
Needle Gauge18 Gauge
Length200 Millimeter
Needle Gauge18 Gauge
Length200 Millimeter
Needle Gauge18 Gauge
Length200 Millimeter
Needle Gauge18 Gauge
Length200 Millimeter
Needle Gauge18 Gauge
Length200 Millimeter
Needle Gauge18 Gauge
Length200 Millimeter
Needle Gauge18 Gauge
Length200 Millimeter
Needle Gauge18 Gauge
Length200 Millimeter
Needle Gauge18 Gauge
Length200 Millimeter
Needle Gauge18 Gauge
Length200 Millimeter
Needle Gauge18 Gauge
Length200 Millimeter
Needle Gauge18 Gauge
Length200 Millimeter
Needle Gauge18 Gauge
Length200 Millimeter
Needle Gauge18 Gauge
Length200 Millimeter
Needle Gauge18 Gauge

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104262410687011 [Primary]
GS104262410687028 [Package]
Contains: 04262410687011
Package: Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNWInstrument, Biopsy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-07
Device Publish Date2025-04-29

Devices Manufactured by ITP Innovative Tomography Products GmbH

04262410687028 - Semi-automatic Biopsy Needle - BIM18/20i2025-05-07The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate).
04262410687028 - Semi-automatic Biopsy Needle - BIM18/20i2025-05-07 The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate).
04262410686090 - Automatic Biopsy Needle - BAM 16/172025-05-01 The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate).
04262410686113 - Automatic Biopsy Needle - BAM 16/152025-05-01 The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate).
04262410680173 - Coaxial Interventional Needle2025-04-16 This needle is intended for puncture and injection.
04262410680357 - Coaxial Interventional Needle2025-03-21 This needle is intended for puncture and injection.
04262410680036 - Coaxial Interventional Needle2025-01-17 This needle is intended for puncture and injection.
04262410680159 - Coaxial Interventional Needle2025-01-17 This needle is intended for puncture and injection.
04262410680197 - Coaxial Interventional Needle2025-01-17 This needle is intended for puncture and injection.

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